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UNKNOWNPHASE1

Safety Study of a Radiolabeled Antibody (7E11) in Patients With Progressive Hormone Refractory Prostate Cancer

A Phase 1 Study of Radiolabeled Monoclonal Antibody 7E11-C5.3(177Lu-meO-DOTA-7E11;CYT-500) in Patients With Progressive Androgen-Independent Prostate Cancer

NCT00441571•Cytogen Corporation

View on ClinicalTrials.gov

Summary

The proposed phase 1 clinical trial will investigate the safety and tolerability of 177Lu-CYT-500 in patients with metastatic prostate cancer and determine the optimal antibody mass and dose of 177Lu to be used for further study.

Detailed Description

The proposed phase I clinical trial will investigate the safety and tolerability of 177Lu-CYT-500 and determine the optimal antibody mass and dose of 177Lu to be used for further study. The biodistribution and pharmacokinetics will also be assessed. Patients with histologically documented prostate cancer that is progressing following castration will be eligible. Two antibody masses will be explored in cohort 1 before dose escalation of the 177Lu begins. If the two antibody masses show no difference in pharmacokinetics or biodistribution, then the lower of the doses will be used. The radiation dose will be escalated in subsequent cohorts. Dose escalation will be permitted when the last patient accrued to the previous cohort has demonstrated count recovery in cycle 1 such that DLT has not been defined.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Histologically documented prostate cancer that is progressing following castration. The disease should not be progressing so as to require palliative treatment within 12 weeks of enrollment based on clinical assessment by the investigator. All patients must have assessable disease by radionuclide and/or radiographic studies.
•Castrate levels of testosterone (\<50 ng/ml).
•Karnofsky performance status \>60%.
•Patients whose initial hormone treatment (exclusive of neoadjuvant hormone therapy) was a combined androgen blockade approach, e.g. an orchiectomy plus an anti-androgen, or gonadotropin releasing hormone analog and an anti-androgen, must show progression of disease following withdrawal of the anti-androgen prior to enrollment.
•Adequate organ function:
•* Hematologic:
•* ANC \>1,500/mm3
•* Platelet count \>100,000/mm3
•* Hepatic: Bilirubin \<1.5 mg/dL and AST\<1.5X's the ULN
•* Renal: Creatinine \<1.5 mg/dL or creatinine clearance \> 60 mL/min.
+5 more criteria

Exclusion Criteria

•Clinically significant cardiac disease (New York Heart Association Class III or IV), or severe debilitating pulmonary disease.
•Active CNS or epidural primary tumor or active CNS or epidural metastases.
•An active uncontrolled infection or an infection requiring intravenous antibiotic treatment.
•Participation in another therapeutic clinical trial with an experimental drug, concurrently or within the 4 weeks prior to dosing in this study.
•Lack of recovery from the myelosuppressive effects of prior radiation therapy or chemotherapy.
•Patients who have undergone diagnostic ProstaScint, Myoscint, or Oncoscint scans, or have undergone any other prior administration of a murine protein for diagnostic or therapeutic purposes, without regard to HAMA test results.
•Patients with a history of autoimmune hepatitis or history of autoimmune disease.
•Prior radiation therapy encompassing \>25% of the bone marrow
•Prior systemic administration of a therapeutic radiolabeled monoclonal antibody.
•Patients who are unwilling to use a condom (even if they have undergone a prior vasectomy) while having intercourse, while taking the drug and for 4 weeks after stopping treatment.

Locations (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Key Dates

Start Date

February 1, 2007

Last Updated

September 10, 2007

Enrollment

ESTIMATED participants

Conditions

Metastatic Prostate Cancer

Interventions

177Lu-CYT-500

DRUG

Contacts

Karen Dwyer

CONTACT

609-750-8272 kdwyer@cytogen.com

Colleen Gramkowski

CONTACT

609-750-8219 cgramkowski@cytogen.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 10, 2007Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety Study of a Radiolabeled Antibody (7E11) in Patients With Progressive Hormone Refractory Prostate Cancer

Inclusion Criteria

Exclusion Criteria

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